Statistically Significant versus Practically Relevant Trend in Stability Data

Bernhard Schmelzer; AndrÉ Mischo; Franz Innerbichler

doi:10.5731/pdajpst.2020.012336

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Statistically Significant versus Practically Relevant Trend in Stability Data

Bernhard Schmelzer, AndrÉ Mischo and Franz Innerbichler

PDA Journal of Pharmaceutical Science and Technology July 2021, 75 (4) 341-356; DOI: https://doi.org/10.5731/pdajpst.2020.012336

Bernhard Schmelzer

Sandoz GmbH, Langkampfen, Austria

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For correspondence: bernhard.schmelzer@novartis.com

AndrÉ Mischo

Sandoz GmbH, Langkampfen, Austria

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Franz Innerbichler

Sandoz GmbH, Langkampfen, Austria

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vol. 75 no. 4 341-356

DOI

https://doi.org/10.5731/pdajpst.2020.012336

PubMed

33608471

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Parenteral Drug Association (PDA)

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1079-7440

Online ISSN

1948-2124

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Published online August 3, 2021.

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previous version (February 19, 2021 - 05:13).
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Bernhard Schmelzer*,
AndrÉ Mischo and
Franz Innerbichler

Sandoz GmbH, Langkampfen, Austria

↵* Corresponding Author: Sandoz GmbH, Biochemiestraße 10, 6336 Langkampfen, Austria; Telephone: +43 5338 200-1390; E-mail: bernhard.schmelzer{at}novartis.com

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Statistically Significant versus Practically Relevant Trend in Stability Data

Bernhard Schmelzer, AndrÉ Mischo, Franz Innerbichler

PDA Journal of Pharmaceutical Science and Technology Jul 2021, 75 (4) 341-356; DOI: 10.5731/pdajpst.2020.012336

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Statistically Significant versus Practically Relevant Trend in Stability Data

Bernhard Schmelzer, AndrÉ Mischo, Franz Innerbichler

PDA Journal of Pharmaceutical Science and Technology Jul 2021, 75 (4) 341-356; DOI: 10.5731/pdajpst.2020.012336

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Keywords

stability
significant change over time
relevant change over time
equivalence test
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